Combination Therapy for the Treatment of Rosacea

Rosacea is a common cutaneous disorder characterized by facial erythema, papules and
pustules and telangiectasias. The clinical manifestations of this disorder are distributed
along the convexities of the face such as the cheeks, chin, nose and central aspects of the
forehead.

The flushing and telangiectasias associated with erythematotelangietatic rosacea (ETR) are
notoriously difficult to treat with standard medications. Patients with ETR have a lower
threshold for irritation from topically applied drugs and these substances may even
exacerbate their symptoms.

Pulsed dye laser (PDL) is widely considered as the treatment of choice for vascular
malformations including telangiectasias, port wine stains and hemangiomas. Several studies
have shown successful treatment of rosacea-associated telangiectasia and erythema with
pulsed dye laser. Moreover, calcium dobesilate (2,5-dihydroxybenzene sulfonate) is a drug
that inhibits vascular smooth muscle cell growth and inhibits cellular proliferation. As a
synthetic inhibitor of fibroblast growth factor (FGF), calcium dobesilate targets angiogenic
growth factors which lead to uncontrolled blood vessel growth. In light of the fact that
angiogenesis has been implicated in erythematotelangietatic rosacea, calcium dobesilate will
be useful in the treatment of this subtype of rosacea.

Thus, combination treatment with PDL and calcium dobsilate will act in a synergistic manner
to reduce the erythema, flushing and telangectasia associated with erythematotelangietatic
rosacea.

If the subject meets the inclusion criteria and informed consent is obtained, the subject
will receive 2.5% calcium dobesilate get to apply to half of the face (randomized). The
subject will also receive pulsed dye laser treatments to the whole face at two week
intervals for a maximum of 3 treatments. The primary endpoint of this study will be the
severity of rosacea at the end of the 20 week study.